Product Integrity Specialist Full Time

This Product Integrity Specialist position is critical in evaluating data for Product Complaints and Adverse Events. The Product Integrity Specialist may create cases, coordinate product retrievals, perform follow-ups via phone, generate follow-up related correspondence and complete additional services for select clients. The Product Integrity Specialist may also prepare, and review, reconciliation reports as needed by clients. This position requires someone with an extreme technical ability for proofreading and keeping a variety of processes and timelines straight within a regulated environment.

Essential Functions:

• Perform case review for Product Complaint (PC) and Adverse Event (AE) cases created by Medical Information to determine next action(s) required (if applicable):
• Coordinate Retrieval for select client companies, if applicable
• Place outbound follow up calls to complete Product.
• Complaint reports and collecting additional information as requested by the client.
• Create letters in response to Product Complaints as directed by the client.
• Additional contracted PC and AE services for select client companies.
• Case entry of electronic correspondence
• Create and run reconciliation reports as needed.
• The Product Integrity Specialist can confidently identify any new or follow-up Adverse Event details and report to appropriate contacts.
• The Product Integrity Specialist can confidently identify any new or follow-up Product Complaint details and report to appropriate contacts.
• Provide administrative support for MI group as needed.
• Manage Product Integrity inbox(es)
• Update existing Product Complaint and Adverse Event cases as appropriate.
• Answer inbound calls and check voicemails.
• Other duties as assigned.

Necessary Skills and Abilities:

• Excellent English language skills especially verbal and written (including proofreading) communication skills.
• Ability to write fluent and grammatically correct American English.
• Working knowledge of medical terminology, regulations, and industry standards.
• Excellent interpersonal skills including empathetic customer service skills.
• Accurate and proficient data entry skills.
• Ability to multi-task with attention to detail within restrictive timeframes.
• Proactive with demonstrative ability to independently identify problems and suggest effective solutions.
• Ability to organize and prioritize in quickly changing environment within resource constraints.
• Ability to take instruction and learn.
• Receptive to constructive feedback.
• Self-motivating. Ability to demonstrate initiative and internal drive. Willingness to seek out additional workload projects.
• Effectively work independently and as part of a team.
• Highly proficient in computer applications, including Microsoft Office software platforms and Adobe Acrobat, and experience using a document management system. Aptitude to learn other computer systems including inquiry handling database.

Educational Requirements:

• Pharmacy Technician, Veterinary Technician, Life Science Grad, or other Healthcare related equivalent required.

Experience Requirements:

• Minimum 1-3 years’ previous experience in an administrative or data entry role.
• At least 1-3 years’ experience in medical or pharmaceutical industry field especially in Medical/Drug Information, Pharmacovigilance, Product Complaints, and/or Quality Assurance preferred.